Overall purpose of job:
This role is responsible for the quality of, and meeting the applicable requirements for, the products that J&J Innovative Medicine markets and/or the products under J&J company which take responsibility by China J&J Innovative Medicine CQ team and quality system maintenance.
He/she is also taking responsible to ensure compliance with the local laws/regulations and the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities J&J Innovative Medicine undertakes. In this role he/she has defined authority and responsibility for ensuring that quality system and processes, as are described in the Quality Manual (QM), are implemented, maintained and is dedicated to continuous improvement thereof.
As the GSP quality head of Johnson & Johnson Pharmaceutical Co., Ltd., this position is fully responsible for GSP drug quality management and has the decision power for drug quality management under the GSP.
Essential duties and responsibilities:
Fully responsible for product quality management, perform duties independently, make decision for product quality management
Organize the establishment and improvement of the company's business quality management system, monitor the system and ensure its effective operation
Establishing and maintaining Quality System via transposition of the applicable requirements (laws, regulations and the elements of the J&J quality policy, standards and procedures etc.).
Ensure the appropriate implementation and follow-up of actions needed to comply with new regulatory standards through existing processes in quality manual.
Conduct regular supervision and inspection of the company's business quality management system, and report the inspection results directly to HA
Organize internal audits on a regular basis when key elements of the quality management system change significantly
Make decision on the company's purchase, storage, sales, transportation and other issues that may affect product quality.
Review and identify the purchase and sales qualification documents, product label instructions, contracts, bills, remittance units, product sources and authenticity, etc
Audit quality management procedures, conduct inspection and assessment of the implementation of quality management procedures
Quality approval for first sale enterprise and first sale product
Research and identify major issues of quality management。
Approval of computer system permissions
Responsible for the supervision, guidance, coordination and approval of validation work
Notify and engage LOC Head of Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or IT compliance, as per the Escalation procedures outlined in Quality Manual.
Provide quality insight to manager and other stakeholders according to statistics data analysis.
Lead and escalate critical product issue and support the recall/field actions in timely manner.
Other works assign by Head of Quality.
Required Knowledge, Skills and Abilities (Uncompromised requirements for the role) :
(Include any required computer skills, certifications, licenses, languages, etc.)
· Fluent English; business-level Mandarin or Korean would be an asset
· Strong business acumen – the ability to understand challenges through the eyes of the Asia Cluster business leaders
· Influencing skills – the ability to persuade others to change behavior in pursuit of a common goal
· Strong leadership and collaboration skills at the senior executive level, as well as with peers in procurement and the business
· Strong verbal and written communication skills, with the ability to confidently present complex information to senior executives
· Broad-based understanding of core procurement areas of focus (spend management, category management and supplier management)
· Strong project and change management capabilities
· Demonstrated learning agility, and the ability to improve both yourself and the people around you